NDC 43386-080

Amlodipine and Valsartan

Amlodipine And Valsartan

Amlodipine and Valsartan is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Amlodipine Besylate; Valsartan.

Product ID43386-080_9d36c4f2-62db-b5f9-e053-2a95a90a239f
NDC43386-080
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine and Valsartan
Generic NameAmlodipine And Valsartan
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-03-30
Marketing CategoryANDA / ANDA
Application NumberANDA202829
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameAMLODIPINE BESYLATE; VALSARTAN
Active Ingredient Strength10 mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 43386-080-03

30 TABLET in 1 BOTTLE (43386-080-03)
Marketing Start Date2015-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43386-080-03 [43386008003]

Amlodipine and Valsartan TABLET
Marketing CategoryANDA
Application NumberANDA202829
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-30

NDC 43386-080-09 [43386008009]

Amlodipine and Valsartan TABLET
Marketing CategoryANDA
Application NumberANDA202829
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-30

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:e05dd72c-7475-422e-bf8e-73148929450e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 722126
  • 722137
  • 722131
  • 722134
  • UPC Code
  • 0343386082094
  • 0343386081035
  • 0343386083039
  • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    Medicade Reported Pricing

    43386008009 AMLODIPINE-VALSARTAN 10-320 MG

    Pricing Unit: EA | Drug Type:

    43386008003 AMLODIPINE-VALSARTAN 10-320 MG

    Pricing Unit: EA | Drug Type: